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Completed

NCT Number: NCT06480981

Multiple Ascending Dose Noribogaine PK/PD in Healthy Volunteers

This trial will be a randomised, double-blind, sequential-group, multiple-dose, placebo-controlled, dose escalation trial to characterise the pharmacokinetics (PK), pharmacodynamics (PD) and safety of noribogaine in healthy adult participants.

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Key information

Conditions

Pharmacokinetics

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Richmond Pharmacology

London, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Ability to provide written, personally signed, and dated informed consent.
  • Healthy male and female participants between the ages of 18 to 45 inclusive.
  • BMI 18 - 30 kg/m2.
  • Non- or ex-smoker.
  • Normal ECG findings i.e. QTcF interval ≤ 450 ms and normal morphology that would permit accurate assessment of the QT interval.
  • Participants must agree to use highly

Exclusion criteria

  • History of, or concurrent clinically significant cardiovascular, dysautonomia, gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic or psychiatric, or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the participant or impact the validity of the study.
  • Family history in first degree relatives for unknown and/or known arrhythmia-related cardiac events, cardiomyopathy, syncope, long QT syndrome, Brugada's syndrome, sudden death attributed to cardiac causes, and familial cardiac channelopathies.
  • Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with interpretation of QTc interval changes.
  • Previous or current alcohol, or other drug dependence.

Treatment and study plan

Noribogaine

Drug

Noribogaine capsules

Primary outcomes

  1. Pharmacokinetics Cmax Day 1

    Time frame: Day 1

    Determination of maximum plasma concentration of noribogaine

  2. Pharmacokinetics Cmax Day 8

    Time frame: Day 8

    Determination of maximum plasma concentration of noribogaine

  3. Pharmacokinetics Tmax Day 1

    Time frame: Day 1

    Determination of the time to reach the maximum plasma concentration of noribogaine

  4. Pharmacokinetics Tmax Day 8

    Time frame: Day 8

    Determination of the time to reach the maximum plasma concentration of noribogaine

  5. Pharmacokinetics AUC0-t Day 1

    Time frame: Day 1

    Determination of the area under the plasma concentration-time curve from time 0 to t of noribogaine

  6. Pharmacokinetics AUC0-t Day 8

    Time frame: Day 8

    Determination of the area under the plasma concentration-time curve from time 0 to t of noribogaine

  7. Pharmacokinetics AUC0-infinity Day 8

    Time frame: Day 8

    Determination of the area under the plasma concentration-time curve from time 0 to infinity of noribogaine

  8. Pharmacokinetics t1/2 Day 1

    Time frame: Day 1

    Determination of elimination half-life (t1/2) of noribogaine

  9. Pharmacokinetics t1/2 Day 8

    Time frame: Day 8

    Determination of elimination half-life (t1/2) of noribogaine

Interested in participating?

Completed

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Sponsors and collaborators

Lead sponsor

DemeRx NB

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Trial to Evaluate Multiple Dose Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Ascending Doses of Noribogaine in Healthy Volunteers.

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Jul 1, 2024
Registry last updated
Jan 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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